ByCategory: Quality & Regulatory Affairs
Job Id: R1264494
Location: Pune, Maharashtra, India / Bangalore, Karnataka, India
Employment Type: Hybrid
About Cytiva:
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Cytiva supports customers undertaking life-saving activities, from fundamental biological research to developing innovative vaccines, medicines, and cell and gene therapies.
As part of Danaher’s Biotechnology segment, Cytiva leverages technical expertise and talent to develop the next generation of life-changing therapeutics. The global team spans over 40 countries, ensuring daily learning opportunities and career growth.
Role Overview:
The Supplier Quality Engineer (SQE) ensures the integrity of products and services, meeting business and customer needs, and complying with regulatory and industry standards. Located in Pune or Bangalore, the role involves hybrid work arrangements.
Key Responsibilities:
- Quality Assurance: Ensure exceptional product quality, patient safety, and regulatory assurance.
- Supplier Management: Lead supplier management activities, including supplier qualification, process qualification, auditing, issue resolution, and continuous improvement.
- Compliance: Ensure supplier compliance to Quality Management Systems (QMS) and regulatory requirements.
- Collaboration: Work with Engineering, Project Management, Business Development, and Sourcing teams to manage supplier quality.
- Continuous Improvement: Develop and execute corrective and preventive action plans, improve supplier quality performance, and implement quality plans.
- Audit and Review: Build and implement supplier audit plans and undertake technical reviews as necessary.
Essential Requirements:
- Problem-Solving Skills: Effective in leading root cause investigations and corrective action plans.
- Auditor Experience: Qualified auditor, experienced in on-site and remote/virtual environments, knowledgeable in industrial process control.
- Quality Management Knowledge: Familiar with QMS tools, continuous improvement methodologies, and Lean principles.
- Education and Experience: Bachelor’s degree in engineering or technical field with experience in manufacturing, engineering, quality assurance, preferably in biotech or pharmaceutical industries.
- Communication and Collaboration: Excellent communication and collaboration skills, able to influence at all levels of the organization.
Work Arrangement:
- Hybrid Work: This position supports a hybrid work arrangement, allowing part-time work from the company location and part-time remote work from home. Additional details will be provided during the interview process.
Why Join Cytiva:
- Impactful Work: Engage in challenges that truly matter and contribute to life-saving activities.
- Career Growth: Continuous learning opportunities and career development.
- Flexible Work Environment: Embrace flexible, hybrid working arrangements.
- Diverse and Inclusive: Work in an environment that values diversity and different perspectives.
Apply Now: Supplier Quality Engineer at Cytiva
